UK Bio Products Laboratory

United Kingdom

UK Bio Products Laboratory

United Kingdom
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Sandle T.,UK Bio Products Laboratory
GMP Review | Year: 2014

The draft WHO paper addresses those parenteral products described in the International Pharmacopoeia that did not have endotoxin limits assigned. In assigning the endotoxin limits, the WHO approach uses the established method for calculating endotoxin limits. This keeps the revision on the same path as that established by the PDG process of international harmonisation. Such harmonisation between the WHO and the Ph.Eur. and USP is, ultimately, in the interest of patients.

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